Identity
- Trade Name
- Roydent FDA UDI
- Generic Name
- Dental root surface conditioner FDA UDI
- Device Name
- C.L. CANAL LUBRICANT (150) FDA UDI
- Model / Reference
- 101 FDA UDI
- Description
- C.L. CANAL LUBRICANT (150) FDA UDI
Identifiers
- Catalog Number
- 101 FDA UDI
- Primary DI / UDI-DI
- D8091011 FDA UDI
- FDA Product Code
- EKL FDA UDI
- GMDN Term
- Dental root surface conditioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2.5 Milliliter FDA UDI
Category: Dental root surface conditioner
Roydent by Roydent Dental Products Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental root surface conditioner.
- REGENX PuraCAL — ACE SURGICAL SUPPLY CO., INC. · Class II
- Brasseler USA — Peter Brasseler Holdings, LLC · U
- ProLube — TULSA DENTAL PRODUCTS LLC · Class I
- MASTER-DENT — DENTONICS, INC.
- ProLube — TULSA DENTAL PRODUCTS LLC · Class I
- REGENX PuraCAL — ACE SURGICAL SUPPLY CO., INC. · Class II
- EdgeEndo® — US Endodontics, LLC · U
- EdgeEndo® — US Endodontics, LLC · U
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roydent Dental Products Inc
Sources (1)
- FDA UDI 5b54edf5-7ecb-4867-a0f6-597252d62c8c 37 fields · synced May 30, 2026